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United States · US · US:0597-0024_aa423748-811c-4bf7-a67f-b38cf394553f

Combivent Respimat

In shortageOrange BookUNIISPLATC R03AC

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0597002402
    1 CARTRIDGE in 1 CARTON (0597-0024-02) / 120 SPRAY, METERED in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
N021747
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Albuterol Sulfate Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "021SEF3731",
    "rxcui": "142153",
    "inchikey": "BNPSSFBOAGDEEL-UHFFFAOYSA-N",
    "display_name": "ALBUTEROL SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "9832312e-0310-4ab6-8501-afa976fc7eb2": {
      "match": "brand_token",
      "title": "COMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]",
      "spl_version": "18",
      "published_date": "2025-12-04"
    }
  },
  "productid": "0597-0024_aa423748-811c-4bf7-a67f-b38cf394553f",
  "productndc": "0597-0024",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "021747",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.1MG BASE/INH;0.02MG/INH",
        "product_no": "001",
        "approval_date": "Oct 7, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALBUTEROL SULFATE; IPRATROPIUM BROMIDE",
  "shortage_reason": "Albuterol Sulfate Solution",
  "shortage_status": "current",
  "proprietary_name": "Combivent Respimat",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA021747",
  "marketing_category": "NDA",
  "nonproprietary_name": "ipratropium bromide and albuterol",
  "start_marketing_date": "20120701",
  "active_numerator_strength": "100; 20"
}

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